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"Ventricular Tachycardia Ablation Registry".

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ClinicalTrials.gov Identifier: NCT03649022
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Paolo Della Bella, IRCCS San Raffaele

Brief Summary:

Catheter ablation of Ventricular Tachycardias is a well-established approach in clinical practice in patients with Implantable Cardioverter Defibrillator (ICD) implanted. Previous studies have shown a significant reduction in appropriate shocks (~ 20%) and a significant reduction in hospitalizations for cardiovascular reasons (~ 12%) in patients with ischemic heart disease treated with ablation. Recent works have also shown the effectiveness of the ablation procedure using as procedural target the reduction of late potentials. However, actually it is necessary to have an homogenize and accepted mapping scheme in Sinus Rhythm to ablate Ventricular Tachycardias related to scar substrate in patients with:

  • Previous MI
  • Previous myocarditis
  • Arrhythmogenic Right Ventricular Dysplasia (ARVD)
  • Idiopathic Dilated Cardiomyopathy (IDCM)

Scope of the registry is to collect data during cardiac mapping in Sinus Rhythm in patients indicated for Ventricular Tachycardia ablation, that will be performed per clinical practice, by using the St. Jude Medical EnSiteTM PrecisionTM mapping system.

The objective of the present registry is: to assess the acute and long-term efficacy of the strategy of substrate abolition (abolishment of complex and late potentials) guided by electroanatomic mapping with Precision software.


Condition or disease Intervention/treatment
Ventricular Tachycardia Device: Catheter ablation

Detailed Description:

This is an Italian multicenter, observational, prospective and retrospective registry.

Data will be collected during enrollment/baseline, procedure, pre-discharge and during the follow-up visits according to the standard practice of participating centers, with mandatory visits at 6 and 12 months. Data can also be collected retrospectively, prior informed consent of the patient.

The planned enrollment duration is approximately 24 months.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: "Ventricular Tachycardia Ablation Registry". Italian Registry of Substrate Mapping and VT Ablation With the Precision Mapping System and Flexability Catheter.
Actual Study Start Date : July 25, 2017
Estimated Primary Completion Date : July 25, 2020
Estimated Study Completion Date : July 25, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Catheter ablation
    Ventricular Tachycardia ablation, that will be performed per clinical practice, by using EnSite Precision mapping system with the Flexability catheter (St.Jude, now Abbott)


Primary Outcome Measures :
  1. Late potential abolition and ventricular tachycardia noninducibility [ Time Frame: Intraprocedural ]

    Combined procedural endpoint of late potential (LP) abolition and VT noninducibility (endpoint expected in 50% of cases).

    LP abolition assessed as % of persistent LP area at remap after ablation, compared to the basal activation map.


  2. Ventricular tachycardia recurrence [ Time Frame: 12 months ]
    Freedom from Ventricular Tachycardia episodes requiring ICD Intervention (shock or Anti-Tachycardia Pacing)


Secondary Outcome Measures :
  1. Complications [ Time Frame: During hospitalization: starting during the procedure until discharge ]
    Periprocedural complications

  2. Complications [ Time Frame: 12 months ]
    Long term catheter ablation complications

  3. Procedural parameters [ Time Frame: Intraprocedural ]
    Procedure duration measured in minutes

  4. Procedural parameters [ Time Frame: Intraprocedural ]
    Fluoroscopy exposure measured in Gycm2

  5. Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott) [ Time Frame: Intraprocedural ]
    Geometry precision, descriptive

  6. Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott) [ Time Frame: Intraprocedural ]
    Mapping accuracy, descriptive

  7. Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott) [ Time Frame: Intraprocedural ]
    System overall stability, descriptive

  8. Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott) [ Time Frame: Intraprocedural ]
    Non-recoverable shifts/drifts, descriptive



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Population of patients with defibrillator, indicated to perform catheter ablation of ventricular tachycardia related to substrate scar due to previous MI, previous myocarditis and arrhythmogenic right ventricular dysplasia, idiopathic dilated cardiomyopathy guided by electroanatomic mapping system.
Criteria

Inclusion Criteria:

  • Patients with an implanted ICD
  • Patients with indication to Ventricular Tachycardia Ablation procedure, supported by EnSite Precision 3D mapping system (previous MI, myocarditis, ARVD, IDCM)
  • Age 18 years or more
  • Able to provide an informed consent to participate to the registry and available to respect the assessments described in the protocol

Exclusion Criteria:

  • Contraindication to anticoagulants
  • Presence of thrombi
  • Presence of Mitral and Aortic prosthetic valve
  • Recent (<3 months) myocardial infarction or unstable angina or Coronary Artery Bypass
  • Pregnant or nursing
  • Ventricular Tachycardia caused by reversible pathology
  • < 1 Year life expectancy according to the investigator
  • Contraindication to the use of ablation/diagnostic catheters or to cardiac catheterism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649022


Contacts
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Contact: Andrea Radinovic, MD +390226437356 radinovic.andrea@hsr.it

Locations
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Italy
IRCCS San Raffaele Recruiting
Milan, Italy, 20132
Contact: Paolo Della Bella, MD    +390226437379    dellabella.paolo@hsr.it   
Contact: Andrea Radinovic, MD    +390226437379    radinovic.andrea@hsr.it   
Sponsors and Collaborators
Paolo Della Bella
Investigators
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Principal Investigator: Paolo Della Bella, MD IRCCS S Raffaele

Additional Information:

Publications:

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Responsible Party: Paolo Della Bella, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03649022     History of Changes
Other Study ID Numbers: OSR-ARITM-001
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes